Medical Devices; Exemption From Premarket Notification; Class II Devices; Powered Wheeled Stretcher
| Published date | 14 January 2020 |
| Citation | 85 FR 2018 |
| Record Number | 2020-00295 |
| Section | Rules and Regulations |
| Court | Food And Drug Administration |
Federal Register, Volume 85 Issue 9 (Tuesday, January 14, 2020)
[Federal Register Volume 85, Number 9 (Tuesday, January 14, 2020)]
[Rules and Regulations]
[Pages 2018-2020]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00295]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 890
[Docket No. FDA-2019-P-3347]
Medical Devices; Exemption From Premarket Notification; Class II
Devices; Powered Wheeled Stretcher
AGENCY: Food and Drug Administration, HHS.
ACTION: Final amendment; final order.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is publishing
an order granting a petition requesting exemption from premarket
notification (510(k)) requirements for powered wheeled stretchers
(product code INK). These devices are battery-powered tables with
wheels that are intended for medical purposes for use by patients who
are unable to propel themselves independently and who must maintain a
prone or supine position for prolonged periods because of skin ulcers
or contractures (muscle contractions). This order exempts powered
wheeled stretchers, class II devices, from 510(k) requirements, subject
to certain conditions for exemption. This exemption from 510(k)
requirements is immediately in effect for powered wheeled stretchers.
FDA is publishing this order in accordance with the section of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) permitting the
exemption of a device from the requirement to submit a 510(k).
DATES: This order is effective January 14, 2020.
FOR FURTHER INFORMATION CONTACT: Eric Franca, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1655, Silver Spring, MD 20993-0002, 301-796-4505,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Statutory Background
Section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and its
implementing regulations in part 807, subpart E (21 CFR part 807,
subpart E) require persons who propose to begin the introduction or
delivery for introduction into interstate commerce for commercial
distribution of a device intended for human use to submit a 510(k) to
FDA. The device may not be marketed until FDA finds it ``substantially
equivalent'' within the meaning of section 513(i) of the FD&C Act (21
U.S.C. 360c(i)) to a legally marketed device that does not require
premarket approval.
On November 21, 1997, the President signed into law the Food and
Drug Administration Modernization Act of 1997 (Pub. L. 105-115),
section 206 of which added section 510(m) to the FD&C Act, which was
amended on December 13, 2016, by the 21st Century Cures Act (Pub. L.
114-255). Section 510(m)(1) of the FD&C Act requires FDA to publish in
the Federal Register a notice that contains a list of each type of
class II device that does not require a report under section 510(k) of
the FD&C Act to provide reasonable assurance of safety and
effectiveness of the device. Section 510(m) of the FD&C Act further
provides that a 510(k) will no longer be required for these devices
upon the date of publication of the list in the Federal Register. FDA
published that list in the Federal Register of January 21, 1998 (63 FR
3142).
Section 510(m)(2) of the FD&C Act provides that FDA may exempt a
device from 510(k) requirements on its own initiative, or upon petition
of an interested person, if FDA determines that a 510(k) is not
necessary to assure the safety and effectiveness of the device. This
section requires FDA to publish in the Federal Register a notice of
intent to exempt a device, or of the petition, and to provide a 60-
calendar-day period for public comment. Within 120 days after the
issuance of the notice, FDA shall publish an order in the Federal
Register setting forth the final determination regarding the exemption
of the device that was the subject of the notice. If FDA fails to
respond to a petition under this section within 180 days of receiving
it, the petition shall be deemed granted.
II. Criteria for Exemption
There are a number of factors FDA may consider to determine whether
a 510(k) is necessary to assure the safety and effectiveness of a class
II device. These factors are discussed in the guidance that the Agency
issued on
[[Page 2019]]
February 19, 1998, entitled ``Procedures for Class II Device Exemptions
from Premarket Notification'' (Class II 510(k) Exemption Guidance).
That guidance can be obtained through the internet at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080199.pdf or by sending an email request to [email protected] to receive a copy of the document. Please use the
document number 159 to identify the guidance you are requesting.
III. Petition
On July 10, 2019, FDA received a petition requesting an exemption
from premarket notification for powered wheeled stretchers (see Docket
No. FDA-2019-P-3347). These devices are currently classified under 21
CFR 890.3690, powered wheeled stretchers.
In the Federal Register of September 16, 2019 (84 FR 48623), FDA
published a notice announcing that this petition had been received and
provided opportunity for interested persons to submit comments on the
petition by November 15, 2019. FDA received no comments.
FDA has assessed the need for 510(k) clearance for this type of
device against the criteria laid out in the Class II 510(k) Exemption
Guidance. Based on this review, FDA believes that premarket
notification is not necessary to assure the safety and effectiveness of
the device, as long as certain conditions are met. FDA believes that
the risks posed by the device and the characteristics of the device
necessary for its safe and effective performance are well established.
FDA believes that changes in the device that could affect safety and
effectiveness will be readily detectable by visual examination.
Therefore, after reviewing the petition, FDA has determined that
premarket notification is not necessary to assure the safety and
effectiveness of powered wheeled stretchers, as long as the conditions
in section IV are met. FDA responded to the petition by letter dated
December 31, 2019, to inform the petitioner of this decision within the
180-day timeframe under section 510(m)(2) of the FD&C Act.
IV. Conditions for Exemption
This final order provides conditions for exemption from premarket
notification for the powered wheeled stretcher.\1\ The conditions that
must be met for the device to be 510(k)-exempt are as follows:
Appropriate analysis and nonclinical testing must demonstrate that the
safety controls are adequate to ensure safe use of the device and
prevent user falls from the device in the event of a device failure;
appropriate analysis and nonclinical testing must demonstrate the
ability of the device to withstand the rated user weight load with an
appropriate factor of safety; appropriate analysis and nonclinical
testing must demonstrate the longevity of the device to withstand
external forces applied to the device and provide the user with an
expected service life of the device; appropriate analysis and
nonclinical testing must demonstrate proper environments of use and
storage of the device to maximize the longevity of the device;
appropriate analysis and nonclinical testing (such as outlined in
appropriate FDA-recognized consensus standards) must validate
electromagnetic compatibility and electrical safety; appropriate
analysis and nonclinical testing (such as outlined in appropriate FDA-
recognized consensus standards) must validate that the skin-contacting
components of the device are biocompatible; appropriate analysis and
nonclinical testing (such as outlined in appropriate FDA-recognized
consensus standards) must validate the software life cycle and that all
processes, activities, and tasks are implemented and documented;
appropriate analysis and nonclinical testing must validate that the
device components are found to be nonflammable; appropriate analysis
and nonclinical testing (such as outlined in appropriate FDA-recognized
consensus standards) must validate that the battery in the device
performs as intended over the anticipated service life of the device;
adequate labeling is provided to the user to document proper use and
maintenance of the device to ensure safe use of the device in the
intended use environment; and appropriate risk assessment including,
but not limited to, evaluating the dimensional limits of the gaps in
hospital beds and mitigation strategy to reduce entrapment.
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\1\ FDA notes that the ``ACTION'' caption for this final order
is styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
Federal Register's (OFR) interpretations of the Federal Register Act
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and
parts 21 and 22), and the Document Drafting Handbook.
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A number of these conditions involve ``appropriate analysis and
nonclinical testing,'' the details of which are outlined in, among
other places, certain FDA-recognized consensus standards. The following
is a list of FDA recognized consensus standards that may be used to
meet the listed conditions of exemption. Specifically, those standards
include FDA-recognized editions of:
ANSI/AAMI ES60601-1: Medical electrical equipment--Part 1:
General requirements for basic safety and essential performance
ANSI/AAMI/IEC 60601-1-2: Medical electrical equipment--Part 1-
2: General requirements for basic safety and essential performance--
Collateral Standard: Electromagnetic disturbances--Requirements and
tests
ISO 7176-14: Wheelchairs--Part 14: Power and control systems
for electrically powered wheelchairs and scooters--Requirements and
test methods
ISO 7176-21: Wheelchairs--Part 21: Requirements and test
methods for electromagnetic compatibility of electrically powered
wheelchairs and scooters, and battery chargers
ANSI/AAMI/ISO 10993-1: Biological evaluation of medical
devices--Part 1: Evaluation and testing within a risk management
process
ANSI/AAMI/ISO 10993-5: Biological evaluation of medical
devices--Part 5: Tests for in vitro cytotoxicity
AAMI/ANSI/ISO 10993-10: Biological evaluation of medical
devices--Part 10: Tests for irritation and skin sensitization
IEC 62304: Medical device software--Software life cycle
processes
ISO 7176-25: Wheelchairs--Part 25: Batteries and chargers for
powered wheelchairs
We also recommend you consider FDA's guidance entitled ``Hospital
Bed System Dimensional and Assessment Guidance to Reduce Entrapment''
when considering the appropriate risk assessment referenced in the
conditions set forth above.
Firms are now exempt from 510(k) requirements for powered wheeled
stretchers as long as they meet these conditions, subject to the
limitations on exemption in 21 CFR 890.9. Firms must comply with the
particular conditions set forth in the conditions for exemption or
submit and receive clearance for a 510(k) prior to marketing.
V. Analysis of Environmental Impact
The Agency has determined under 21 CFR 25.30(h) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
VI. Paperwork Reduction Act of 1995
This final order refers to previously approved FDA collections of
[[Page 2020]]
information. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3521). The collections of information in 21
CFR part 820, regarding quality system regulation, have been approved
under OMB control number 0910-0073; the collections of information in
part 807, subpart E, regarding premarket notification submissions, have
been approved under OMB control number 0910-0120; and the collections
of information in 21 CFR parts 801 and 809, regarding labeling, have
been approved under OMB control number 0910-0485.
List of Subjects in 21 CFR Part 890
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
890 is amended as follows:
PART 890--PHYSICAL MEDICINE DEVICES
0
1. The authority citation for part 890 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. In Sec. 890.3690, revise paragraph (b) to read as follows:
Sec. 890.3690 Powered wheeled stretcher.
* * * * *
(b) Classification. Class II (performance standards). The powered
wheeled stretcher is exempt from premarket notification procedures in
subpart E of part 807 of this chapter, subject to Sec. 890.9, and the
following conditions for exemption:
(1) Appropriate analysis and nonclinical testing must demonstrate
that the safety controls are adequate to ensure safe use of the device
and prevent user falls from the device in the event of a device
failure;
(2) Appropriate analysis and nonclinical testing must demonstrate
the ability of the device to withstand the rated user weight load with
an appropriate factor of safety;
(3) Appropriate analysis and nonclinical testing must demonstrate
the longevity of the device to withstand external forces applied to the
device and provide the user with an expected service life of the
device;
(4) Appropriate analysis and nonclinical testing must demonstrate
proper environments of use and storage of the device to maximize the
longevity of the device;
(5) Appropriate analysis and nonclinical testing (such as outlined
in appropriate FDA-recognized consensus standards) must validate
electromagnetic compatibility and electrical safety;
(6) Appropriate analysis and nonclinical testing (such as outlined
in appropriate FDA-recognized consensus standards) must validate that
the skin-contacting components of the device are biocompatible;
(7) Appropriate analysis and nonclinical testing (such as outlined
in appropriate FDA-recognized consensus standards) must validate the
software life cycle and that all processes, activities, and tasks are
implemented and documented;
(8) Appropriate analysis and nonclinical testing must validate that
the device components are found to be nonflammable;
(9) Appropriate analysis and nonclinical testing (such as outlined
in appropriate FDA-recognized consensus standards) must validate that
the battery in the device performs as intended over the anticipated
service life of the device;
(10) Adequate labeling is provided to the user to document proper
use and maintenance of the device to ensure safe use of the device in
the intended use environment; and
(11) Appropriate risk assessment including, but not limited to,
evaluating the dimensional limits of the gaps in hospital beds, and
mitigation strategy to reduce entrapment.
Dated: January 7, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-00295 Filed 1-13-20; 8:45 am]
BILLING CODE 4164-01-P
